Nature Cell showed confidence in obtaining conditional approval for Jointstem from the Ministry of Drug and Food Safety (MFDS) after it presented the U.S. phase 2 clinical trial results for the treatment.
Jointstem, co-developed with Biostar, is a stem cell degenerative arthritis treatment.
|Professor Timothy Davis, an orthopedic pain specialist from the Cedars Sinai Medical Center in L.A., presents U.S. phase 2 clinical trials for Jointstem, at the Chosun Westin Hotel in downtown Seoul, Monday.|
Professor Timothy Davis, an orthopedic pain specialist from the Cedars Sinai Medical Center in L.A., presented the clinical trial results, which confirmed the efficacy of the treatment. The trial evaluated the treatment's efficacy by assessing criteria such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogue Scale (VAS), International Knee Documentation Committee score (IKDC) and patient satisfaction.
According to U.S. clinical trial results, after a year of being treated with Jointstem, the WOMAC score decreased from 36.38~60.12 to 9.29~30.09, while the VAS score decreased from 57.00~79.58 to 13.17~33.30. The result also showed an increase in patient satisfaction from 59.50~65.17 to 67.67~73.75 during the same time. The treatment also confirmed cartilage repair effect through an MRI and showed no significant adverse impact.
“The clinical trial identified new possibilities of treating severe degenerative arthritis patients with a simple injection of Jointstem instead of surgery,” said Davis. “By confirming safety and efficacy in clinical trials, many degenerative arthritis patients around the world can now have a treatment option that has no side effects.”
The company said it expects to receive conditional approval from the ministry based on the trial results.
“In addition to the trial results, the company confirmed that Jointstem showed meaningful results compared to the U.S. Food and Drug Administration’s approved comparison degenerative arthritis drug," said Ra Jeong-chan, CEO of Nature Cell and Biostar. "The company also confirmed treatment efficacy on 93 percent of the patients participating in the clinical trials.”
The company expects that the conditional approval will play a significant role in increasing national interest by attracting not only domestic patients but also foreign patients, Ra added.
According to the Health Insurance Review and Assessment Agency, the number of patients with degenerative arthritis in Korea was approximately 3.6 million in 2016. If Jointstem receives conditional approval, it will become the first treatment approved to treat such patients. Currently, surgery is the only viable option for degenerative arthritis patients.
<© Korea Biomedical Review, All rights reserved.>